Freelance Local Contact Person for Pharmacovigilance and Regulatory Affairs

Job summary
Exciting opportunity for a freelancer to join our team as Local Contact Personfor Pharmacovigilance and Regulatory AffairsOpportunities are open to any geographical location and with flexible working hoursWork in an international team and strengthen your expertise within the broad and diverse PV and Regulatory Affairs area
Job seniority: mid-to-senior level
Responsibilities
• Primary Contact Person for local regulatory authority / Pharmacovigilance expert as per local requirements• Prompt and effective communication with local regulatory authorities• Provision of local regulatory intelligence screening and expert advice• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)• Local management / oversight of risk minimization measures related to urgent safety restrictions and emerging safety issues• Review and linguistic input on local Product Information and Mock-ups• Perform local non-indexed literature screening and screening of Regulatory Authority website/s for potential Adverse Drug Reactions (ADRs) and safety information• Support audits and Inspections• Handle local QA tasks such as suspected falsified products, quality alerts received from HA) and other quality-related requirements received from the local market
Requirements
• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent experience• Demonstrated experience within pharmaceutical or CRO industry or Regulatory body• Demonstrated experience within LCPPV / LCPRA roles• PV training and/or working experience and other educational or professional background as required locally• Expert knowledge of ICH GVP and most relevant legislation/ local requirements for territories of competency• Proficiency in English, both written and verbal and in local language• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint